DEVICE: Piccolo Comprehensive Metabolic Panel (EABA40000281)
Device Identifier (DI) Information
Piccolo Comprehensive Metabolic Panel
400-0028
In Commercial Distribution
400-0028
ABAXIS, INC.
400-0028
In Commercial Distribution
400-0028
ABAXIS, INC.
The Piccolo® Comprehensive Metabolic Panel, used with the Piccolo® blood chemistry analyzer or the Piccolo Xpress® chemistry analyzer, is intended to be used for the in vitro quantitative determination of alanine aminotransferase (ALT), albumin, alkaline phosphatase (ALP), aspartate aminotransferase (AST), calcium, chloride, creatinine, glucose, potassium, sodium, total bilirubin, total carbon dioxide, total protein, and blood urea nitrogen (BUN) in heparinized whole blood, heparinized plasma, or serum in a clinical laboratory setting or point-of-care location.
The tests on this panel are waived under CLIA ’88 regulations. If a laboratory modifies the test system instructions, then the tests are considered high complexity and subject to all CLIA requirements. For CLIA waived labs, only lithium heparin whole blood may be tested. For use in moderate complexity labs, lithium heparinized whole blood, lithium heparinized plasma, or serum may be used.
Device Characteristics
| Labeling does not contain MRI Safety Information | |
| No | |
| No | |
| Yes | |
| No | |
| No | |
| No | |
| No | |
| No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
| GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
|---|---|---|---|---|
| 52879 | Chloride (Cl-) IVD, reagent |
A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of chloride (Cl-) in a clinical specimen.
|
Active | false |
| 52955 | Total aspartate aminotransferase (AST) IVD, reagent |
A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of total aspartate aminotransferase (AST) in a clinical specimen.
|
Active | false |
| 53307 | Glucose IVD, reagent |
A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of glucose in a clinical specimen.
|
Active | false |
| 53231 | Total bilirubin IVD, reagent |
A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of total bilirubin in a clinical specimen.
|
Active | false |
| 53989 | Total protein IVD, reagent |
A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of total protein in a clinical specimen.
|
Active | false |
| 53599 | Albumin IVD, reagent |
A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of albumin in a clinical specimen.
|
Active | false |
| 53252 | Creatinine IVD, reagent |
A substance or reactant intended to be used together with other IVDs to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of creatinine in a clinical specimen.
|
Active | false |
| 53590 | Urea IVD, reagent |
A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of urea or urea nitrogen [also known as blood urea nitrogen (BUN)] in a clinical specimen.
|
Active | false |
| 52925 | Alanine aminotransferase (ALT) IVD, reagent |
A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of alanine aminotransferase (ALT) in a clinical specimen.
|
Active | false |
| 52929 | Total alkaline phosphatase (ALP) IVD, reagent |
A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of total alkaline phosphatase (ALP) in a clinical specimen.
|
Active | false |
| 52875 | Calcium (Ca2+) IVD, reagent |
A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of calcium (Ca2+) in a clinical specimen.
|
Active | false |
| 52895 | Potassium (K+) IVD, reagent |
A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of potassium (K+) in a clinical specimen.
|
Active | false |
| 52873 | Bicarbonate (HCO3-) IVD, reagent |
A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of bicarbonate (HCO3-) in a clinical specimen.
|
Obsolete | false |
| 52898 | Sodium (Na+) IVD, control |
A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of sodium (Na+) in a clinical specimen.
|
Active | false |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| CHJ | Mercuric Thiocyanate, Colorimetry, Chloride |
| CIT | Nadh Oxidation/Nad Reduction, Ast/Sgot |
| CGA | Glucose Oxidase, Glucose |
| CIG | Diazo Colorimetry, Bilirubin |
| CEK | Biuret (Colorimetric), Total Protein |
| CJW | Bromcresol Purple Dye-Binding, Albumin |
| CGX | Alkaline Picrate, Colorimetry, Creatinine |
| CDN | Urease, Photometric, Urea Nitrogen |
| CKA | Nadh Oxidation/Nad Reduction, Alt/Sgpt |
| CKF | Phenylphosphate, Alkaline Phosphatase Or Isoenzymes |
| CJY | Azo Dye, Calcium |
| CEM | Electrode, Ion Specific, Potassium |
| KHS | Enzymatic, Carbon-Dioxide |
| JGS | Electrode, Ion Specific, Sodium |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| K010670 | 000 |
| K934592 | 000 |
| K942782 | 000 |
| K950164 | 000 |
| K992140 | 000 |
| K993211 | 000 |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| Storage Environment Temperature: between 36 and 46 Degrees Fahrenheit |
| Storage Environment Temperature: between 2 and 8 Degrees Celsius |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| No Device Sizes |
Device Record Status
8c27b57f-200b-4f4c-941a-4a014647cc4d
December 20, 2022
5
September 23, 2016
December 20, 2022
5
September 23, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]| Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
|---|---|---|---|---|---|
| No Package DIs found | |||||
Secondary DI
[?]| Issuing Agency [?] | Secondary DI Number |
|---|---|
| No Secondary DIs found | |
Unit of Use DI
[?]
Unit of Use DI Number:
EABA40000280
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
1-800-822-2947
Piccolo@abaxis.com +49 6155780210
abaxis@abaxis.de +1 (510) 675 6500
abaxis@abaxis.com
Piccolo@abaxis.com +49 6155780210
abaxis@abaxis.de +1 (510) 675 6500
abaxis@abaxis.com